The Quality Control Lab Manager position is responsible for managing all activities associated with the daily operation of the Laboratory Services. This includes training, evaluating, and directing laboratory staff, reviewing, and implementing customer’s test methods, implementing new technology, investigating and resolving technical issues related to the laboratory services. This position will be responsible for prioritizing testing schedules in an efficient way that meets the need of the manufacturing, production, and customer Service departments.

The Manager also participates in quality related activities outside of the laboratory services and is the primary point person between the laboratory and other departments.

Essential Duties and Responsibilities include but are not limited to the following:

· Assure that testing priorities to support OPS and Customer Service schedules.

· Ensure final data completion, review, and proper documentation to comply with all company policies, SOPs, cGMP, GDP, and relevant industry, regulatory and safety requirements

· Follow up and communicate status of “hot” items, and manage them in collaboration with respective departments.

· Develop contingency plans to support production needs

· Assure adequate communication of priorities exists between the lab and other departments and within the lab from shift to shift.

· Provide guidance to troubleshoot issues regarding instruments, test methods, lab chemicals, standards, and samples.

· Maintain knowledge of customer’s specifications and testing procedures.

· Assure that all raw materials, bulks, and finished goods are tested in accordance with customer specification and priority basis.

· Assure test failures are investigated and documented, and that corrective action is taken, by following regulatory guidelines.

· Evaluate lifecycle of laboratory instruments.

· Ensure the IQ/OQ, and PQ of laboratory instrumentation.

· Ensure data integrity of laboratory data

· Establish department KPI and metrics.

· Assess new test methodology and requirements of new product launch

· Resolve test method issues which involves interaction with customer’s technical staff. Respond to technical questions from customers about laboratory issues.

· Evaluate time and cost aspects of laboratory work associated with new products launch and provide technical support

· Assist in investigation of OPS by providing supporting data

· Coordinate outside lab testing to support releases.

· Develop and implement continuous improvement plans of laboratory productivity, cost control and output.

· Review and approve SOP’s, specifications, and other documentation required to administer the laboratory.

· Participate as SME in customer audits and regulatory audits

· Perform other duties as assigned.

Minimum Requirements of the Job:

· Experience in pharmaceutical product testing / Quality Control.

· Knowledge and experience with Total Quality Management Systems, Statistical Process Control, and other quality management philosophies.

· Thorough understanding of compendial testing methodology, analytical chemistry and chemical instrumentation, particularly HPLC and GC.

· Effective interpersonal, leadership, and organizational skills.

· Fluency in written and spoken English.

· Ability to use computers for word processing and data analysis

· Ability to manage many diverse tasks and issues simultaneously, through prioritization, delegation, and “hands-on” personal effort in a fast paced, high-volume environment.

· Understanding of laboratory safety requirements and the MSDS system.

· Understanding of LIMS , TrackWise and ELN systems

· Ability to read, comprehend, and interpret technical data.

· Ability to represent Accupac to customers and regulatory agencies.

Physical Requirements:

· Sitting for 40 - 50% of the workday.

· Walking/standing up to six hours each work day.

· Hear/Execute clear speech, in person and over the telephone.

· Lift/Carry items up to 40 pounds.

· Hear phones ring, alarms sound through ambient noise and everyday conversation.

· Possess color vision.

Supervisory Responsibilities: Analytical Laboratory Supervisors, Shift Leads and Analytical Chemists

Travel : Minimal

Education and/or Experience : Bachelor’s Degree in Analytical Chemistry or Chemistry from a four-year college is required. MS degree in Analytical Chemistry is preferred. Minimum of five years management experience in the pharmaceutical industry is a must.
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